RU2018100129A - GHOST TREATMENT METHODS - Google Patents

GHOST TREATMENT METHODS Download PDF

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RU2018100129A
RU2018100129A RU2018100129A RU2018100129A RU2018100129A RU 2018100129 A RU2018100129 A RU 2018100129A RU 2018100129 A RU2018100129 A RU 2018100129A RU 2018100129 A RU2018100129 A RU 2018100129A RU 2018100129 A RU2018100129 A RU 2018100129A
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antibody
fragment
doses
dose
reduction
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Алан М. Солингер
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Ксома (Сша) Ллс
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    • C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
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    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
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    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A61P19/06—Antigout agents, e.g. antihyperuricemic or uricosuric agents
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A61P29/02—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] without antiinflammatory effect
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    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
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    • C07K2317/00—Immunoglobulins specific features
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    • C07K2317/00—Immunoglobulins specific features
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    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
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    • C07—ORGANIC CHEMISTRY
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    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/34—Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
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    • C07—ORGANIC CHEMISTRY
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    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
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    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value

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Claims (74)

1. Способ лечения подагры у субъекта, где способ включает введение анти-ИЛ-1β антитела или его фрагмента этому субъекту.1. A method for treating gout in a subject, the method comprising administering an anti-IL-1β antibody or fragment thereof to the subject. 2. Способ по п. 1, в котором подагра представляет собой хроническую подагру.2. The method of claim 1, wherein the gout is chronic gout. 3. Способ по п. 1, в котором подагра представляет собой острую подагру.3. The method of claim 1, wherein the gout is acute gout. 4. Способ по пп. 1-3, в котором антитело или фрагмент антитела связывает человеческий ИЛ-1β с константой диссоциации приблизительно 10 нМ или менее.4. The method according to PP. 1-3, in which the antibody or antibody fragment binds human IL-1β with a dissociation constant of about 10 nM or less. 5. Способ по п. 4, в котором антитело или фрагмент антитела связывает человеческий ИЛ-1β с константой диссоциации приблизительно 10 нМ или менее.5. The method of claim 4, wherein the antibody or antibody fragment binds human IL-1β with a dissociation constant of about 10 nM or less. 6. Способ по п. 5, в котором антитело или фрагмент антитела связывает человеческий ИЛ-1β с константой диссоциации приблизительно 500 пМ или менее.6. The method of claim 5, wherein the antibody or antibody fragment binds human IL-1β with a dissociation constant of about 500 pM or less. 7. Способ по п. 6, в котором антитело или фрагмент антитела связывает человеческий ИЛ-1β с константой диссоциации приблизительно 250 пМ или менее.7. The method of claim 6, wherein the antibody or antibody fragment binds human IL-1β with a dissociation constant of about 250 pM or less. 8. Способ по п. 7, в котором антитело или фрагмент антитела связывает человеческий ИЛ-1β с константой диссоциации приблизительно 10 пМ или менее. 8. The method of claim 7, wherein the antibody or antibody fragment binds human IL-1β with a dissociation constant of about 10 pM or less. 9. Способ по п. 8, в котором антитело или фрагмент антитела связывает человеческий ИЛ-1β с константой диссоциации приблизительно 1 пМ или менее.9. The method of claim 8, wherein the antibody or antibody fragment binds human IL-1β with a dissociation constant of about 1 pM or less. 10. Способ по п. 9, в котором антитело или фрагмент антитела связывает человеческий ИЛ-1β с константой диссоциации приблизительно 0,5 пМ или менее.10. The method of claim 9, wherein the antibody or antibody fragment binds human IL-1β with a dissociation constant of about 0.5 pM or less. 11. Способ по п. 10, в котором антитело или фрагмент антитела связывает человеческий ИЛ-1β с константой диссоциации приблизительно 0,3 пМ или менее. 11. The method of claim 10, wherein the antibody or antibody fragment binds human IL-1β with a dissociation constant of about 0.3 pM or less. 12. Способ по пп. 1-11, в котором анти-ИЛ-1β антитело или фрагмент антитела представляет собой нейтрализующее антитело.12. The method according to PP. 1-11, in which the anti-IL-1β antibody or antibody fragment is a neutralizing antibody. 13. Способ по пп. 1-11, в котором анти-ИЛ-1β антитело или фрагмент антитела связывает эпитоп ИЛ-1β, так что связанное антитело или фрагмент существенно позволяет ИЛ-1β связываться с рецептором ИЛ-1 I (ИЛ-1RI). 13. The method according to PP. 1-11, in which the anti-IL-1β antibody or antibody fragment binds the epitope of IL-1β, so that the associated antibody or fragment substantially allows IL-1β to bind to the IL-1 I receptor (IL-1RI). 14. Способ по пп. 1-11, в котором антитело или фрагмент антитела не проявляет обнаруживающего связывания с ИЛ-1α, ИЛ-1R или ИЛ-1Ra.14. The method according to PP. 1-11, in which the antibody or antibody fragment does not show detectable binding to IL-1α, IL-1R or IL-1Ra. 15. Способ по пп. 1-11, в котором антитело или фрагмент антитела связывает эпитоп, содержащийся в последовательности ESVDPKNYPKKKMEKRFVFNKIE. 15. The method according to PP. 1-11, in which the antibody or antibody fragment binds an epitope contained in the sequence ESVDPKNYPKKKMEKRFVFNKIE. 16. Способ по пп. 1-11, в котором антитело или его фрагмент конкурирует за связывание с антителом с вариабельным доменом легкой цепи SEQ ID NO: 5 и вариабельным доменом тяжелой цепи SEQ ID NO: 6.16. The method according to PP. 1-11, in which the antibody or fragment thereof competes for binding to the antibody with the variable domain of the light chain of SEQ ID NO: 5 and the variable domain of the heavy chain of SEQ ID NO: 6. 17. Способ по пп. 1-11, в котором антитело или фрагмент антитела связывает эпитоп, включающий Glu64 из ИЛ-1β.17. The method according to PP. 1-11, in which the antibody or antibody fragment binds an epitope comprising Glu64 from IL-1β. 18. Способ по пп. 1-11, в котором антитело или фрагмент антитела связывает аминокислоты 1-34 N-конца ИЛ-1β.18. The method according to PP. 1-11, in which the antibody or antibody fragment binds amino acids 1-34 of the N-terminus of IL-1β. 19. Способ по пп. 1-11, в котором антитело или фрагмент антитела является гуманизированным или полученным с помощью генетической инженерии.19. The method according to PP. 1-11, in which the antibody or antibody fragment is humanized or obtained by genetic engineering. 20. Способ по пп. 1-11, в котором антитело или фрагмент антитела является человеческим.20. The method according to PP. 1-11, in which the antibody or antibody fragment is human. 21. Способ по пп. 1-20, в котором антитело или фрагмент антитела вводят одной или несколькими дозами по 3 мг/кг антитела или фрагмента или менее. 21. The method according to PP. 1-20, in which the antibody or antibody fragment is administered in one or more doses of 3 mg / kg of the antibody or fragment or less. 22. Способ по п. 21, в котором антитело или фрагмент антитела вводят одной или несколькими дозами по 1 мг/кг антитела или фрагмента или менее.22. The method according to p. 21, in which the antibody or antibody fragment is administered in one or more doses of 1 mg / kg of antibody or fragment or less. 23. Способ по п. 22, в котором антитело или фрагмент антитела вводят одной или несколькими дозами по 0,3 мг/кг антитела или фрагмента или менее. 23. The method according to p. 22, in which the antibody or antibody fragment is administered in one or more doses of 0.3 mg / kg of the antibody or fragment or less. 24. Способ по п. 23, в котором антитело или фрагмент антитела вводят одной или несколькими дозами по 0,1 мг/кг антитела или фрагмента или менее. 24. The method of claim 23, wherein the antibody or antibody fragment is administered in one or more doses of 0.1 mg / kg of the antibody or fragment or less. 25. Способ по п. 24, в котором антитело или фрагмент антитела вводят одной или несколькими дозами по 0,03 мг/кг антитела или фрагмента или менее. 25. The method according to p. 24, in which the antibody or antibody fragment is administered in one or more doses of 0.03 mg / kg of the antibody or fragment or less. 26. Способ по п. 25, в котором антитело или фрагмент антитела вводят одной или несколькими дозами по 0,01 мг/кг антитела или фрагмента или менее. 26. The method of claim 25, wherein the antibody or antibody fragment is administered in one or more doses of 0.01 mg / kg of antibody or fragment or less. 27. Способ по п. 26, в котором антитело или фрагмент антитела вводят одной или несколькими дозами по 0,003 мг/кг антитела или фрагмента или менее. 27. The method of claim 26, wherein the antibody or antibody fragment is administered in one or more doses of 0.003 mg / kg of the antibody or fragment or less. 28. Способ по п. 27, в котором антитело или фрагмент антитела вводят одной или несколькими дозами по 0,001 мг/кг антитела или фрагмента или менее. 28. The method according to p. 27, in which the antibody or antibody fragment is administered in one or more doses of 0.001 mg / kg of antibody or fragment or less. 29. Способ по пп. 21-28, в котором одна или более доз составляет, по меньшей мере, 0,001 мг/кг антитела или фрагмента. 29. The method according to PP. 21-28, in which one or more doses is at least 0.001 mg / kg of antibody or fragment. 30. Способ по пп. 21-26, в котором одна или более доз составляет, по меньшей мере, 0,01 мг/кг антитела или фрагмента. 30. The method according to PP. 21-26, in which one or more doses is at least 0.01 mg / kg of antibody or fragment. 31. Способ по пп. 1-20, в котором антитело или фрагмент антитела вводят одной или несколькими дозами от 0,001 мг/кг до 1 мг/кг. 31. The method according to PP. 1-20, in which the antibody or antibody fragment is administered in one or more doses from 0.001 mg / kg to 1 mg / kg. 32. Способ по п. 31, в котором антитело или фрагмент антитела вводят одной или несколькими дозами от 0,001 мг/кг до 0,3 мг/кг. 32. The method of claim 31, wherein the antibody or antibody fragment is administered in one or more doses from 0.001 mg / kg to 0.3 mg / kg. 33. Способ по п. 31, в котором антитело или фрагмент антитела вводят одной или несколькими дозами от 0,003 мг/кг до 1 мг/кг. 33. The method of claim 31, wherein the antibody or antibody fragment is administered in one or more doses from 0.003 mg / kg to 1 mg / kg. 34. Способ по п. 33, в котором антитело или фрагмент антитела вводят одной или несколькими дозами от 0,003 мг/кг до 0,3 мг/кг. 34. The method of claim 33, wherein the antibody or antibody fragment is administered in one or more doses from 0.003 mg / kg to 0.3 mg / kg. 35. Способ по пп. 1-20, в котором антитело или фрагмент вводят в виде фиксированной дозы независимо от отношения дозы к весу субъекта. 35. The method according to PP. 1-20, in which the antibody or fragment is administered as a fixed dose regardless of the ratio of dose to weight of the subject. 36. Способ по п. 35, в котором антитело или фрагмент вводят одной или несколькими дозами по 500 мг антитела или фрагмента или меньше. 36. The method of claim 35, wherein the antibody or fragment is administered in one or more doses of 500 mg of antibody or fragment or less. 37. Способ по п. 36, в котором антитело или фрагмент вводят одной или несколькими дозами по 250 мг антитела или фрагмента или меньше. 37. The method of claim 36, wherein the antibody or fragment is administered in one or more doses of 250 mg of antibody or fragment or less. 38. Способ по п. 37, в котором антитело или фрагмент вводят одной или несколькими дозами по 100 мг антитела или фрагмента или меньше. 38. The method of claim 37, wherein the antibody or fragment is administered in one or more doses of 100 mg of antibody or fragment or less. 39. Способ по п. 38, в котором антитело или фрагмент вводят одной или несколькими дозами по 25 мг антитела или фрагмента или меньше. 39. The method of claim 38, wherein the antibody or fragment is administered in one or more doses of 25 mg of antibody or fragment or less. 40. Способ по п. 39, в котором антитело или фрагмент вводят одной или несколькими дозами по 10 мг антитела или фрагмента или меньше. 40. The method of claim 39, wherein the antibody or fragment is administered in one or more doses of 10 mg of antibody or fragment or less. 41. Способ по п. 40, в котором антитело или фрагмент вводят одной или несколькими дозами по 1,0 мг антитела или фрагмента или меньше. 41. The method of claim 40, wherein the antibody or fragment is administered in one or more doses of 1.0 mg of antibody or fragment or less. 42. Способ по пп. 35-41, в котором антитело или фрагмент вводят одной или несколькими дозами, по меньшей мере, по 0,1 мг антитела или фрагмента. 42. The method according to PP. 35-41, in which the antibody or fragment is administered in one or more doses of at least 0.1 mg of the antibody or fragment. 43. Способ по п. 42, в котором антитело или фрагмент вводят одной или несколькими дозами, по меньшей мере, по 1,0 мг антитела или фрагмента. 43. The method of claim 42, wherein the antibody or fragment is administered in one or more doses of at least 1.0 mg of the antibody or fragment. 44. Способ по пп. 35-40, в котором антитело или фрагмент вводят одной или несколькими дозами, по меньшей мере, по 10 мг антитела или фрагмента. 44. The method according to PP. 35-40, in which the antibody or fragment is administered in one or more doses of at least 10 mg of the antibody or fragment. 45. Способ по пп. 1-44, в котором анти-ИЛ-1β антитело или фрагмент вводят подкожно, внутривенно или внутримышечно. 45. The method according to PP. 1-44, wherein the anti-IL-1β antibody or fragment is administered subcutaneously, intravenously or intramuscularly. 46. Способ по пп. 1-45, в котором после введения начальной дозы антитела или фрагмента антитела следует введение одной или нескольких последующих доз. 46. The method according to PP. 1-45, in which after the introduction of the initial dose of the antibody or antibody fragment, the introduction of one or more subsequent doses. 47. Способ по пп. 1-45, в котором после введения начальной дозы антитела или фрагмента антитела следует введение одной или нескольких последующих доз, и в котором указанные одна или несколько последующих доз приблизительно равны начальной дозе или меньше ее. 47. The method according to PP. 1-45, in which after the introduction of the initial dose of the antibody or antibody fragment, the introduction of one or more subsequent doses, and in which these one or more subsequent doses are approximately equal to the initial dose or less. 48. Способ по пп. 1-45, в котором после введения начальной дозы антитела или фрагмента антитела следует введение одной или нескольких последующих доз, и в котором указанные одна или несколько последующих доз больше, чем начальная доза. 48. The method according to PP. 1-45, in which after the introduction of the initial dose of the antibody or antibody fragment, the introduction of one or more subsequent doses, and in which the specified one or more subsequent doses is greater than the initial dose. 49. Способ по пп. 1-48, в котором доза антитела или фрагмента достаточна для обеспечения, по меньшей мере, 50% уменьшения боли в суставах. 49. The method according to PP. 1-48, in which the dose of the antibody or fragment is sufficient to provide at least a 50% reduction in joint pain. 50. Способ по п. 49, в котором доза антитела или фрагмента достаточна для обеспечения, по меньшей мере, 60% уменьшения боли в суставах. 50. The method of claim 49, wherein the dose of the antibody or fragment is sufficient to provide at least a 60% reduction in joint pain. 51. Способ по п. 50, в котором доза антитела или фрагмента достаточна для обеспечения, по меньшей мере, 70% уменьшения боли в суставах. 51. The method of claim 50, wherein the dose of the antibody or fragment is sufficient to provide at least a 70% reduction in joint pain. 52. Способ по п. 51, в котором доза антитела или фрагмента достаточна для обеспечения, по меньшей мере, 80% уменьшения боли в суставах. 52. The method of claim 51, wherein the dose of the antibody or fragment is sufficient to provide at least an 80% reduction in joint pain. 53. Способ по п. 52, в котором доза антитела или фрагмента достаточна для обеспечения, по меньшей мере, 90% уменьшения боли в суставах. 53. The method of claim 52, wherein the dose of the antibody or fragment is sufficient to provide at least a 90% reduction in joint pain. 54. Способ по п. 52, в котором доза антитела или фрагмента достаточна для обеспечения, по меньшей мере, 95% уменьшения боли в суставах. 54. The method of claim 52, wherein the dose of the antibody or fragment is sufficient to provide at least a 95% reduction in joint pain. 55. Способ по пп. 1-54, в котором доза антитела или фрагмента достаточна для обеспечения, по меньшей мере, 20% снижения уровня СРБ. 55. The method according to PP. 1-54, in which the dose of the antibody or fragment is sufficient to provide at least a 20% reduction in CRP. 56. Способ по п. 55, в котором доза антитела или фрагмента достаточна для обеспечения, по меньшей мере, 30% снижения уровня СРБ. 56. The method of claim 55, wherein the dose of the antibody or fragment is sufficient to provide at least a 30% reduction in CRP. 57. Способ по п. 56, в котором доза антитела или фрагмента достаточна для обеспечения, по меньшей мере, 40% снижения уровня СРБ. 57. The method of claim 56, wherein the dose of the antibody or fragment is sufficient to provide at least a 40% reduction in CRP. 58. Способ по п. 57, в котором доза антитела или фрагмента достаточна для обеспечения, по меньшей мере, 50% снижения уровня СРБ. 58. The method of claim 57, wherein the dose of the antibody or fragment is sufficient to provide at least a 50% reduction in CRP. 59. Способ по п. 58, в котором доза антитела или фрагмента достаточна для обеспечения, по меньшей мере, 70% снижения уровня СРБ. 59. The method of claim 58, wherein the dose of the antibody or fragment is sufficient to provide at least a 70% reduction in CRP. 60. Способ по п. 59, в котором доза антитела или фрагмента достаточна для обеспечения, по меньшей мере, 90% снижения уровня СРБ. 60. The method of claim 59, wherein the dose of the antibody or fragment is sufficient to provide at least a 90% reduction in CRP. 61. Способ по пп. 1-54, в котором доза антитела или фрагмента достаточна для обеспечения, по меньшей мере, 20% снижения СОЭ. 61. The method according to PP. 1-54, in which the dose of the antibody or fragment is sufficient to provide at least 20% reduction in ESR. 62. Способ по п. 61, в котором доза антитела или фрагмента достаточна для обеспечения, по меньшей мере, 40% снижения СОЭ. 62. The method of claim 61, wherein the dose of the antibody or fragment is sufficient to provide at least a 40% reduction in ESR. 63. Способ по п. 62, в котором доза антитела или фрагмента достаточна для обеспечения, по меньшей мере, 60% снижения СОЭ. 63. The method of claim 62, wherein the dose of the antibody or fragment is sufficient to provide at least a 60% reduction in ESR. 64. Способ по п. 63, в котором доза антитела или фрагмента достаточна для обеспечения, по меньшей мере, 70% снижения СОЭ. 64. The method of claim 63, wherein the dose of the antibody or fragment is sufficient to provide at least a 70% reduction in ESR. 65. Способ по п. 64, в котором доза антитела или фрагмента достаточна для обеспечения, по меньшей мере, 80% снижения СОЭ. 65. The method of claim 64, wherein the dose of the antibody or fragment is sufficient to provide at least an 80% reduction in ESR. 66. Способ по п. 65, в котором доза антитела или фрагмента достаточна для обеспечения, по меньшей мере, 90% снижения СОЭ. 66. The method of claim 65, wherein the dose of the antibody or fragment is sufficient to provide at least a 90% reduction in ESR. 67. Способ по пп. 1-54, в котором доза антитела или фрагмента достаточна для обеспечения, по меньшей мере, 50% уменьшения боли в суставах, по меньшей мере, 20% снижения уровня СРБ и, по меньшей мере, 20% снижения СОЭ. 67. The method according to PP. 1-54, in which the dose of the antibody or fragment is sufficient to provide at least a 50% reduction in joint pain, at least a 20% reduction in CRP and at least a 20% reduction in ESR. 68. Способ по п. 67, в котором доза антитела или фрагмента достаточна для обеспечения, по меньшей мере, 30% снижения уровня СРБ и, по меньшей мере, 30% снижения СОЭ. 68. The method of claim 67, wherein the dose of the antibody or fragment is sufficient to provide at least a 30% reduction in CRP and at least a 30% reduction in ESR. 69. Способ по п. 68, в котором доза антитела или фрагмента достаточна для обеспечения, по меньшей мере, 40% снижения уровня СРБ и, по меньшей мере, 40% снижения СОЭ. 69. The method of claim 68, wherein the dose of the antibody or fragment is sufficient to provide at least a 40% reduction in CRP and at least a 40% reduction in ESR. 70. Способ по пп. 1-69, в котором указанный способ совмещен, по меньшей мере, с одним дополнительным способом лечения, где указанный дополнительный способ лечения включает введение, по меньшей мере, одной фармацевтической композиции, содержащей активный агент, отличный от ИЛ-1β антитела или фрагмента. 70. The method according to PP. 1-69, wherein said method is combined with at least one additional treatment method, wherein said additional treatment method comprises administering at least one pharmaceutical composition containing an active agent other than an IL-1β antibody or fragment. 71. Способ по п. 70, в котором, по меньшей мере, одна указанная фармацевтическая композиция, содержащая активный агент, отличный от ИЛ-1β антитела или фрагмента, выбрана из группы, состоящей из нестероидных противовоспалительных средств (НПВС), кортикостероидов, адренокортикотропного гормона и колхицинов. 71. The method according to p. 70, in which at least one of the specified pharmaceutical composition containing an active agent other than IL-1β antibody or fragment selected from the group consisting of non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, adrenocorticotropic hormone and colchicines. 72. Способ по пп. 1-71, в котором антитело или его фрагмент обладает более низкой IC50, чем антагонист рецептора ИЛ-1β человека в анализе ингибирования ИЛ-1β с цельной кровью, в котором измеряют индуцированную ИЛ-1β продукцию ИЛ-8. 72. The method according to PP. 1-71, in which the antibody or fragment thereof has a lower IC 50 than the human IL-1β receptor antagonist in the whole blood IL-1β inhibition assay, in which IL-1β-induced IL-8 production is measured. 73. Применение анти-ИЛ-1β антитела или его фрагмента, которое обладает более низким IC50, чем IC50 антагониста рецептора ИЛ-1β человека в анализе ингибирования ИЛ-1β с цельной кровью, в котором измеряют индуцированную ИЛ-1β продукцию ИЛ-8, для производства композиции для использования в лечении подагры. 73. Use of an anti-IL-1β antibody or fragment thereof that has a lower IC 50 than the IC 50 of a human IL-1β receptor antagonist in a whole blood IL-1β inhibition assay, in which IL-1β-induced IL-8 production is measured , for the manufacture of a composition for use in the treatment of gout. 74. Способ по п. 72, в котором ИЛ-1β антагонист рецептора представляет собой Анакирна. 74. The method of claim 72, wherein the IL-1β receptor antagonist is Anakirna.
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